Cerebral Perfusion Pressure Using Precedex and Other Sedatives

Duke University89 enrolled

Overview

The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.

Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects. Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Endotracheal Intubation Continuous IV Sedation ICP Monitoring

Interventions

Standard-of-Care plus DexmedetomidineDRUG

Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment

Standard-of-CareOTHER

Subjects who are treated with the standard of care sedation regiment only.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admitted to Duke University Neuro Critical Care Unit (NCCU) * Adult (18 years of age or older) * Expected Mechanical Ventilation for \>48 hours with sedation * Intraventricular catheter in situ Exclusion Criteria: * Hypersensitivity to study drugs * Prisoners * Moribund state or death expected within 24 hours * Surgery planned within 24 hours of subject enrollment * Receiving study drug, Precedex, prior to entering study

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Variability of Intracranial Pressure (ICP)

Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours

Time frame: Baseline to 24 hours

Change in Pressure Reactivity Index (PRx)

Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP). A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.

Time frame: Baseline to 24 hours

Secondary Outcomes

Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury

Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.

Time frame: 24 hours

Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury

Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.

Time frame: Baseline to 24 hours

Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury

Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.

Data from ClinicalTrials.gov

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